Randomized,double-blind,placebo-controlled,safety and immunogenicity study of 4 formulations of Anthrax Vaccine Adsorbed plus CPG 7909 (AV7909) in healthy adult volunteers |
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| Authors: | Robert J. Hopkins Nancy F. Daczkowski Paulina E. Kaptur Derek Muse Eric Sheldon Craig LaForce Suha Sari Thomas L. Rudge Edward Bernton |
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| Affiliation: | 1. Emergent BioSolutions Inc., Gaithersburg, MD, USA;2. Jean Brown Research, Salt Lake City, UT, USA;3. Miami Research Associates, South Miami, FL, USA;4. North Carolina Clinical Research, Raleigh, NC, USA;5. Battelle Memorial Institute, Columbus, OH, USA |
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| Abstract: | A new anthrax vaccine that could accelerate the immune response and possibly reduce the number of injections needed for protection would be desirable in a post-exposure setting. |
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| Keywords: | ACIP, Advisory Committee on Immunization Practices AE, adverse event ALC, absolute lymphocyte count ANOVA, analysis of variance AVA, Anthrax Vaccine Adsorbed AV7909, AVA plus CPG 7909 CI, confidence interval CPG, cytosine-phosphate-guanine oligonucleotide CRP, C-reactive protein EBS, Emergent BioSolutions Inc. ELISA, enzyme-linked Immunosorbent assay GI, gastrointestinal GMT, geometric mean titer HLA, human leukocyte antigen IFN, interferon IL, interleukin IM, intramuscular IP, interferon-inducible protein NF50, 50% neutralization factor ODN, oligodeoxynucleotide PA, protective antigen PBMC, peripheral blood mononuclear cells PEP, post-exposure prophylaxis rPA, recombinant protective antigen SAE, serious adverse event SC, subcutaneous SD, standard deviation SEM, standard error of the mean Th1, type of T helper cell TNA, toxin neutralizing antibody TRL, toll-like receptor |
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